(32 days)
Not Found
No
The description focuses on the mechanical and electrical functions of a standard electrosurgical pencil with smoke evacuation. There is no mention of AI, ML, or any computational processing beyond basic electrical activation.
Yes
The device is described as an electrosurgical pencil used for cutting and coagulation, which are therapeutic interventions.
No
This device is an electrosurgical pencil designed for surgical applications (cutting and coagulation) and smoke evacuation, not for diagnosing medical conditions.
No
The device description clearly outlines a physical electrosurgical pencil with hardware components like a handpiece, electrodes, tubing, and electrical cable. It is externally powered and connects to a generator. There is no mention of software being the primary or sole component of the device.
Based on the provided text, the Neptune E-SEP is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery." This describes a surgical tool used directly on a patient during a procedure.
- Device Description: The description details a "monopolar electrosurgical pencil" with electrodes and smoke evacuation capabilities. This is consistent with a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Neptune E-SEP is a surgical tool used for treatment and smoke removal during surgery.
N/A
Intended Use / Indications for Use
The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.
Product codes
GEI
Device Description
The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is a single use monopolar electrosurgical pencil that includes a handpiece with a smoke evacuation function and a range of electrodes (both uncoated and coated). The electrosurgical pencil is compact in size (190 mm long and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and associated electrical cable housed within the tubing. The device is externally powered via an external power generator (supplied by user) connected to a monopolar receptacle using a conventional 3-pin connector. This device remains unchanged from the cleared predicate pencil.
The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is available in two activation switch configurations, a rocker style and push-button style, which activates monopolar cut or coagulate functions operated by pressing the respective button. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume.
Electrodes are available in Blade, Needle, Ball, T-Bar Loop, U-Bar Loop and Conization geometries and are listed in Table 6-1 below
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
General
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the proposed devices as determined by the risk analysis for the products. The following areas were evaluated:
Electrical Safety Testing
Functional / Performance Testing
Thermal spread testing
Biocompatibility testing
Sterilization and packaging testing
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use and support a determination of substantial equivalence.
No clinical testing was deemed necessary for this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Stryker Corporation Mairead Twomey Senior Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K153679
Trade/Device Name: Stryker Neptune E-SEP Smoke Evacuation Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 18, 2015 Received: December 21, 2015
Dear Mairead Twomey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Neptune® E-SEP™ Smoke Evacuation Pencil
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
| Contact Details | |
|---|---|
| 510(k) Owner | Stryker Instruments |
| 4100 E. Milham Avenue | |
| Kalamazoo, Michigan 49001 USA | |
| Ph: +353-21-4532988 | |
| Fax: +1-269-324-5412 | |
| FDA Establishment | |
| Registration No. | 1811755 |
| Contact Person | Mairead Twomey |
| Senior Staff Regulatory Affairs Specialist | |
| Ph: +353-21-4532988 | |
| Fax: +1-269-389-5412 | |
| Mairead.Twomey@stryker.com | |
| Date Submitted | December 18, 2015 |
| Device Name | |
| Trade Name | Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Classification | Class II |
| Primary Classification | |
| Name | Electrosurgical, cutting & coagulation & accessories |
| (21 CFR 884.4400, Product code GEI) | |
| Reason for 510(k) | |
| Submission | Special 510(k) – Device modifications and line extension with no |
| change to fundamental scientific technology or intended use | |
| Device Modification and | |
| Line Extension | The line of electrodes offered for use with the Stryker E-SEP |
| Pencil will be expanded to include the following: | |
| • Addition of different length of electrodes as well as additional | |
| geometries (Needle, Ball, Wire (Loop T-Bar, Loop U-Bar, | |
| Conization) – this is a line extension to enable marketing of a | |
| more competitive offering | |
| • New materials present in new offering of electrodes: | |
| ◦ ABS Plastic (Polylac PA-757) has been added as a plastic | |
| over-mold for longer electrodes | |
| ◦ Different grade of stainless steel for the rod and tip of the bar | |
| and wire [Loop T-Bar, Loop U-Bar, Conization] electrodes | |
| This line extension does not change the intended use, indications | |
| for use or the fundamental scientific technology of the system. |
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Image /page/4/Picture/2 description: The image shows the logo for Stryker, a medical technology company. The logo is in black and white and features the company name in a bold, sans-serif font. A registered trademark symbol is located to the upper right of the name.
| Legally Marketed Predicate Device(s) | |||
|---|---|---|---|
| 510(k) Number | |||
| Predicate | Product Code | Trade Name | Manufacturer |
| K143145 | GEI | SafeAir Smoke Pencil* | Lina Medical Aps |
| *SafeAir Smoke Pencil is currently marketed as Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil | |||
| after acquisition by Stryker in 2014. | |||
| These predicate devices have not been the subject of a design related recall. | |||
| Indications for Use | |||
| The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) | |||
| designed for general electrosurgical applications including cutting and | |||
| coagulation, and for removing smoke generated by electrosurgery | |||
| when used in conjunction with an effective smoke evacuation system. | |||
| The pencil enables the operator to remotely conduct an electrosurgical | |||
| current from the output connector of an electrosurgical unit | |||
| (generator) to the operative site for the desired surgical effect. | |||
| Device Description | |||
| The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is a single use | |||
| monopolar electrosurgical pencil that includes a handpiece with a | |||
| smoke evacuation function and a range of electrodes (both uncoated | |||
| and coated). The electrosurgical pencil is compact in size (190 mm long | |||
| and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and | |||
| associated electrical cable housed within the tubing. The device is | |||
| externally powered via an external power generator (supplied by user) | |||
| connected to a monopolar receptacle using a conventional 3-pin | |||
| connector. This device remains unchanged from the cleared predicate | |||
| pencil. |
The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is available in
two activation switch configurations, a rocker style and push-button
style, which activates monopolar cut or coagulate functions operated
by pressing the respective button. The pencil is connected to smoke
evacuation tubing which features a dual connector (8 and 22 mm) to
allow the user to connect to a variety of smoke evacuation systems
including filtration or central vacuum systems, thus minimizing
exposure of personnel to surgical smoke plume.
Electrodes are available in Blade, Needle, Ball, T-Bar Loop, U-Bar Loop
and Conization geometries and are listed in Table 6-1 below | | | |
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Image /page/5/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and the letters are closely spaced together. A small, circled "R" symbol is located to the upper right of the word, indicating that it is a registered trademark. The background of the image is plain white.
| Model Numbers | Model Descriptions |
|---|---|
| 0703-070-000 | Neptune ® E-SEP ™ 70mm Blade Electrode Coated * |
| 0703-070-001 | Neptune ® E-SEP ™ 70mm Blade Electrode * |
| 0703-125-000 | Neptune ® E-SEP ™ 125mm Blade Electrode Coated |
| 0703-125-001 | Neptune ® E-SEP ™ 125mm Blade Electrode |
| 0703-165-000 | Neptune ® E-SEP ™ 165mm Blade Electrode Coated |
| 0703-165-001 | Neptune ® E-SEP ™ 165mm Blade Electrode |
| 0703-007-070 | Neptune ® E-SEP ™ 70mm Needle Electrode |
| 0703-120-003 | Neptune ® E-SEP ™ 3mm Ball Electrode |
| 0703-120-005 | Neptune ® E-SEP ™ 5mm Ball Electrode |
| 0703-213-015 | Neptune ® E-SEP ™ Conization Electrode W13 D15 L120 |
| 0703-213-020 | Neptune ® E-SEP ™ Conization Electrode W13 D20 L120 |
| 0703-216-008 | Neptune ® E-SEP ™ Conization Electrode W16 D8 L120 |
| 0703-216-018 | Neptune ® E-SEP ™ Conization Electrode W16 D18 L 120 |
| 0703-220-020 | Neptune ® E-SEP ™ Conization Electrode W20 D20 L120 |
| 0703-310-010 | Neptune ® E-SEP ™ Loop T-bar Electrode W10 D10 L120 |
| 0703-315-012 | Neptune ® E-SEP ™ Loop T-bar Electrode W15 D12 L120 |
| 0703-320-015 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D15 L120 |
| 0703-320-020 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D20 L120 |
| 0703-620-015 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D15 L60 |
| 0703-620-020 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D20 L60 |
| 0703-720-020 | Neptune ® E-SEP ™ Loop U-Bar Electrode W20 D20 L120 |
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Image /page/6/Picture/2 description: The image shows the logo for Stryker, a medical technology company. The logo is in black and white and features the word "stryker" in a bold, sans-serif font. A registered trademark symbol is located to the right of the word.
| Performance Data
(Non-Clinical Tests) | The results of the performance testing demonstrate that the
functionality, integrity, and safety and effectiveness of the electrodes
for use with the Neptune E-SEP pencil is sufficient for their intended
use and support a determination of substantial equivalence to the
predicate device. | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Summary of Performance
Testing | Performance testing was conducted on the proposed devices as
determined by the risk analysis for the products. The following areas
were evaluated:
Electrical Safety Testing Functional / Performance Testing Thermal spread testing Biocompatibility testing Sterilization and packaging testing Results of these tests demonstrate that the functionality, integrity, and
safety and effectiveness of the subject devices are sufficient for their
intended use and support a determination of substantial equivalence. | |
| Clinical Tests | No clinical testing was deemed necessary for this 510(k). | |
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Image /page/7/Picture/1 description: The image contains the text "510(k) Summary for K153679" on the left side of the image. To the right of the text is the Stryker logo. The Stryker logo is in bold, black font. There is a registered trademark symbol to the right of the logo.
Table 6-2: Summary of Predicate Comparison
| | Description | SafeAir Smoke Pencil [Predicate] K143145
(Currently marketed as the Neptune® E-SEP™
Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation
of Difference |
|---------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Regulatory Information | 510(k) | K143145 | Not yet assigned | N/A |
| | Product Code | GEI | GEI | Same |
| | Indication for
Use | SafeAir Smoke Pencil is designed for general
electrosurgical applications including cutting and
coagulation, and for removing smoke generated by
electrosurgery when used in conjunction with an
effective smoke evacuation system. The pencil
enables the operator to remotely conduct an
electrosurgical current from the output connector
of an electrosurgical unit to the operative site for
the desired surgical effect. | The Neptune E-SEP is an Integrated Smoke Evacuation Pencil
(pencil) designed for general electrosurgical applications
including cutting and coagulation, and for removing smoke
generated by electrosurgery when used in conjunction with an
effective smoke evacuation system. The pencil enables the
operator to remotely conduct an electrosurgical current from
the output connector of an electrosurgical unit (generator) to
the operative site for the desired surgical effect. | Same.
Stryker
Corporation
acquired the
SafeAir
Smoke Pencil
in 2014. |
| | Classification of
Device | Class II | Class II | Same |
| | Regulation
Number | 21 CFR 884.4400 | 21 CFR 884.4400 | Same |
| | Regulation
Name | Electrosurgical cutting and coagulation device and
accessories | Electrosurgical cutting and coagulation device and accessories | Same |
| | Condition of
Use | Single Use | Single Use | Same |
| | Type of Use | Prescription Use Only | Prescription Use Only | Same |
| | Patient
Population | General | General | Same |
| | Contra -
indications | Do not use monopolar electrosurgery on small
appendages, as in circumcision or finger surgery. | Do not use monopolar electrosurgery on small appendages, as
in circumcision or finger surgery. | Same |
| Description | | SafeAir Smoke Pencil [Predicate] K143145
(Currently marketed as the Neptune® E-SEP™
Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation
of Difference |
| | Overall Design | Device designed to integrate smoke evacuation
into electrosurgery by combining both features
into a single handpiece. | Device designed to integrate smoke evacuation into
electrosurgery by combining both features into a single
handpiece. | Same |
| Overall Design Concept | Power Supply | Monopolar Generator supplied by user | Monopolar Generator supplied by user | Same |
| | Voltage Rating | Maximum 6.0 kV peak | Maximum 5.5 kV peak | Similar |
| | | Electrical
Connector | US-3-Pin | US-3-Pin |
| | | Electrical Safety
Testing | IEC 60601-1
IEC 60601-2-2 | IEC 60601-1
IEC 60601-2-2 |
| | Sterility | Sterile Single Use Only, EtO sterilized
SAL = $10^{-6}$ | Sterile Single Use Only, EtO sterilized
SAL = $10^{-6}$ | Same |
| | Packaging | Single pencil unit with preassembled blade and
suction sleeve, holster and clip in an individual
Tyvek sealed pouch, sold 10 per box. | Single pencil unit with preassembled blade and suction sleeve,
holster and clip in an individual Tyvek sealed pouch, sold 10 per
box.
Electrodes will also be offered individually packaged in a Tyvek
sealed pouch, sold 10 per box. | Similar |
| Description | | SafeAir Smoke Pencil [Predicate] K143145
(Currently marketed as the Neptune® E-SEP™
Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation
of Difference |
| | Electrode Rod
Material | 303 Series Stainless Steel. | 303 Series Stainless Steel.
This material is being used in 7 of the 21 new electrode rods.
The rods of the blade and needle electrodes are made from 303
series Stainless Steel. | Same |
| | | This grade of stainless steel was not present in the
predicate device. | 304 Series Stainless Steel
This material is being used in the remaining 14 of the 21 new
electrode rods. The rods of the ball, conization and loop
electrodes are made from 304 series Stainless Steel. | Similar |
| | Electrode Rod
Diameter | 2.36 mm | 2.36 mm | Same |
| Electrode Technology and Materials | Electrode
Connector
Feature | Pentagon Connector
Image: green pentagon connector | Pentagon Connector
Image: green pentagon connector | Same |
| | Electrode
Connector
Material | Polypropylene (Bormed RF830MO)
70 mm blade coated | Polypropylene (Bormed RF830MO)
70 mm blade coated &
70 mm needle | Same |
| | Electrode
Connector
Material | H1500 Polypropylene
70mm Blade Electrode (uncoated) | H1500 Polypropylene
70mm Blade Electrode (uncoated) | Same |
| | | Connector material (ABS Polylac PA-757) was not
present on the predicate device. | ABS Polylac PA-757 (ABS Plastic) – new connector material
present on the Blade, Conization, T-Bar & U-Bar Loop, Ball
electrodes.
Image: Electrode Connector | Different |
| Description | | SafeAir Smoke Pencil [Predicate] K143145
(Currently marketed as the Neptune® E-SEP™
Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation
of Difference |
| Electrode Technology
and Materials | Electrode Over
Mold Insulation
(only applicable
to longer
electrode
lengths) | Insulation material (ABS Polylac PA-757 ) was not
present on the predicate device | ABS Polylac PA-757 is present on longer length electrodes
including the 125mm, 165 mm Blade Electrodes, Ball
Electrodes, Needle Electrode, T-bar and U-bar Loop Electrodes
and the Conization Electrodes.
Image: Electrode Over Mold Insulation | Different |
| | Electrode tip
material | 303 Series Stainless Steel | 303 Series Stainless Steel
This material is being used in 7 of the 21 new electrode tips.
The tips of the blade and needle electrodes are made from 303
series Stainless Steel. | Same |
| | | This grade of stainless steel was not present in the
predicate device. | 302 Series Stainless Steel
304 Series Stainless Steel | Similar |
| | Electrode tip
coating | PTFE (Polytetraflouroethylene) | PTFE (Polytetrafluoroethylene) | Same |
| | Electrode tip
working length | 70 mm | 70 mm - 165 mm | Different |
| | Electrode tip
geometry | Blade (coated and uncoated)
Image: Electrode tip geometry | Blade (coated and uncoated)
Image: Electrode tip geometry | Same |
| Description | | SafeAir Smoke Pencil [Predicate] K143145
(Currently marketed as the Neptune® E-SEP™
Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation
of Difference |
| | Electrode tip
geometry | Needle
Compatibility with the Colorado MicroDissection
needle was cleared previously | Needle
Image: Needle | Same |
| | | Not applicable – these geometries were not
previously cleared | U-Bar, T-Bar, Conization and Ball
Image: U-Bar, T-Bar, Conization and Ball | Different |
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Image /page/8/Picture/1 description: The image shows the text "510(k) Summary for K153679" on the top left. To the right of this text is the Stryker logo. The Stryker logo is in black and has a registered trademark symbol next to it.
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Image /page/9/Picture/1 description: The image shows the title "510(k) Summary for K153679" on the left side of the image. On the right side of the image is the Stryker logo. The Stryker logo is in bold, black font and has a registered trademark symbol next to it.
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Image /page/10/Picture/1 description: The image contains the text "510(k) Summary for K153679" on the left side of the image. To the right of the text is the Stryker logo. The Stryker logo is in bold black font with a registered trademark symbol.
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Image /page/11/Picture/1 description: The image shows the text '510(k) Summary for K153679' on the left side. On the right side of the image is the Stryker logo. The Stryker logo is in black and has a registered trademark symbol.
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Image /page/12/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase, and the word is black. There is a registered trademark symbol to the right of the word. The word is likely a company logo.
Conclusion/Substantial Equivalence Rationale
The Stryker E-SEP Pencil and Accessories are either identical or similar in intended use, indications for use, technological characteristics, safety and effectiveness to the previously cleared Pencil. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications and line extension of electrodes introduced raise no new issues of safety and effectiveness.
Therefore, the subject device is at least as safe and effective as the predicate and evidence supports a determination of substantial equivalence.